Bisoprolol Fumarate recalls
The FDA has published 4 recalls involving Bisoprolol Fumarate since 2021. The latest was reported on 11 Feb 2026. Most were for nitrosamine impurity. Glenmark Pharmaceuticals Inc., U has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls4since 2021
Last 12 months2reported
Class I00% of total
Ongoing2latest 11 Feb 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 50%Class III 2 50%
Why bisoprolol fumarate is recalled
Companies
By year
Ongoing bisoprolol fumarate recalls
2 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bisoprolol Fumarate and Hydrochlorothiazide tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Unichem Pharmaceuticals USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., U | Packaging Defects | Nationwide |
All bisoprolol fumarate recalls, newest first
4 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bisoprolol Fumarate and Hydrochlorothiazide tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Unichem Pharmaceuticals USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., U | Packaging Defects | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., U | Potency & Assay | Nationwide |
| Drug | CLASS II | Bisoprolol Fumarate And Hydrochlorothiazide Tablets 5 mg/6.25 mg recalledBisoprolol Fumarate And Hydrochlorothiazide | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
Should you stop taking Bisoprolol Fumarate?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.